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TPLC
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Device
mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
Definition
Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Product Code
PAH
Regulation Number
878.3300
Device Class
2
Premarket Reviews
Manufacturer
Decision
AMERICAN MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
AMERICAN MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
2
CALDERA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
COLOPLAST A/S
SUBSTANTIALLY EQUIVALENT
2
MPATHY MEDICAL DEVICES, LTD.
SUBSTANTIALLY EQUIVALENT
1
PROMEDON S.A.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
334
334
2015
274
274
2016
697
697
2017
127
127
2018
173
173
2019
297
297
2020
171
171
2021
318
318
2022
159
159
2023
154
154
2024
58
58
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1045
1045
Insufficient Information
623
623
Material Erosion
182
182
Migration
158
158
Break
139
139
Appropriate Term/Code Not Available
130
130
Migration or Expulsion of Device
88
88
Extrusion
68
68
Material Protrusion/Extrusion
52
52
Device Operates Differently Than Expected
48
48
Detachment of Device or Device Component
43
43
Positioning Failure
40
40
Patient-Device Incompatibility
38
38
Material Twisted/Bent
28
28
Positioning Problem
28
28
Device Appears to Trigger Rejection
25
25
Other (for use when an appropriate device code cannot be identified)
24
24
No Apparent Adverse Event
19
19
Detachment Of Device Component
18
18
Material Deformation
16
16
Malposition of Device
14
14
Bent
13
13
Defective Device
12
12
Difficult to Advance
11
11
Device Dislodged or Dislocated
11
11
Premature Activation
10
10
Fracture
9
9
Material Split, Cut or Torn
9
9
Patient Device Interaction Problem
7
7
Missing Information
6
6
Loose or Intermittent Connection
6
6
Therapeutic or Diagnostic Output Failure
6
6
Torn Material
6
6
Improper or Incorrect Procedure or Method
5
5
Material Fragmentation
5
5
Material Separation
5
5
Unexpected Therapeutic Results
5
5
Difficult To Position
4
4
Unintended Movement
4
4
Device Or Device Fragments Location Unknown
3
3
Deformation Due to Compressive Stress
3
3
Leak/Splash
3
3
Difficult or Delayed Separation
3
3
Separation Problem
2
2
Device-Device Incompatibility
2
2
Component Falling
2
2
Disconnection
2
2
Entrapment of Device
2
2
Inadequacy of Device Shape and/or Size
2
2
Device Slipped
2
2
Stretched
2
2
Device Inoperable
2
2
Defective Component
2
2
Activation, Positioning or Separation Problem
2
2
Difficult to Remove
2
2
Material Too Rigid or Stiff
2
2
Obstruction of Flow
2
2
Split
2
2
Contamination of Device Ingredient or Reagent
1
1
Expulsion
1
1
Device Packaging Compromised
1
1
Missing Value Reason
1
1
Activation Failure
1
1
Material Integrity Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Human-Device Interface Problem
1
1
Device Contaminated During Manufacture or Shipping
1
1
Incomplete or Missing Packaging
1
1
Tear, Rip or Hole in Device Packaging
1
1
Unstable
1
1
Use of Device Problem
1
1
Device Emits Odor
1
1
Unsealed Device Packaging
1
1
Disassembly
1
1
Contamination
1
1
Crack
1
1
Degraded
1
1
Difficult or Delayed Positioning
1
1
Mechanical Problem
1
1
Material Frayed
1
1
Hole In Material
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pain
1229
1229
Erosion
696
696
Incontinence
577
577
Injury
427
427
Urinary Tract Infection
288
288
Urinary Retention
275
275
Unspecified Infection
268
268
No Code Available
226
226
Micturition Urgency
196
196
Dysuria
159
159
Dyspareunia
151
151
Urinary Frequency
147
147
Urinary Incontinence
136
136
No Information
127
127
Hemorrhage/Bleeding
124
124
Prolapse
123
123
No Clinical Signs, Symptoms or Conditions
116
116
Surgical procedure
103
103
Death
99
99
Insufficient Information
99
99
Discomfort
96
96
Scar Tissue
92
92
Abnormal Vaginal Discharge
89
89
Inflammation
89
89
Scarring
86
86
Abdominal Pain
84
84
No Consequences Or Impact To Patient
84
84
Emotional Changes
81
81
No Known Impact Or Consequence To Patient
80
80
Not Applicable
77
77
Hematuria
76
76
Blood Loss
66
66
Constipation
62
62
Other (for use when an appropriate patient code cannot be identified)
61
61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
54
54
Foreign Body Reaction
47
47
Complaint, Ill-Defined
47
47
Burning Sensation
46
46
Obstruction/Occlusion
41
41
Internal Organ Perforation
40
40
Perforation
38
38
Intermenstrual Bleeding
36
36
Bacterial Infection
34
34
Fistula
33
33
Tissue Damage
33
33
Nerve Damage
30
30
Foreign Body In Patient
29
29
Laceration(s)
29
29
Cramp(s) /Muscle Spasm(s)
29
29
Depression
28
28
Edema
27
27
Genital Bleeding
26
26
Nausea
26
26
Muscle Weakness
24
24
Adhesion(s)
24
24
Disability
23
23
Abscess
23
23
Wound Dehiscence
21
21
Hematoma
21
21
Unspecified Kidney or Urinary Problem
21
21
Muscle Spasm(s)
21
21
Failure of Implant
20
20
Deformity/ Disfigurement
20
20
Fever
20
20
Device Embedded In Tissue or Plaque
20
20
Anxiety
19
19
Pocket Erosion
17
17
Fatigue
17
17
Bleeding
17
17
Itching Sensation
17
17
Skin Erosion
17
17
Unspecified Mental, Emotional or Behavioural Problem
16
16
Swelling
16
16
Vomiting
15
15
Numbness
14
14
Discharge
14
14
Abrasion
13
13
Sexual Dysfunction
13
13
Sepsis
13
13
Fibrosis
13
13
Kidney Infection
13
13
Fungal Infection
12
12
Hypersensitivity/Allergic reaction
12
12
Patient Problem/Medical Problem
12
12
Swelling/ Edema
12
12
Neurological Deficit/Dysfunction
11
11
Irritation
10
10
Sleep Dysfunction
10
10
Fecal Incontinence
10
10
Cyst(s)
10
10
Anemia
9
9
Calcium Deposits/Calcification
9
9
Distress
9
9
Diarrhea
9
9
Abdominal Cramps
8
8
Skin Inflammation/ Irritation
8
8
Therapeutic Response, Decreased
8
8
Headache
7
7
Granuloma
7
7
Cramp(s)
7
7
Recalls
Manufacturer
Recall Class
Date Posted
1
Astora
II
Nov-16-2015
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